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FDA 510(k)

KOSMO Femoral Stem

K-Number: K202768 · 2021-04-01

ApplicantB-One Ortho, Corp.
Decision Date2021-04-01
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

KOSMO Femoral Stem is a medical device manufactured by B-One Ortho, Corp.. It received FDA 510(k) clearance on 2021-04-01 under approval number K202768. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KOSMO Femoral Stem?

KOSMO Femoral Stem is a medical device that received FDA 510(k) clearance on 2021-04-01. It is manufactured by B-One Ortho, Corp.. The 510(k) number is K202768.

When was KOSMO Femoral Stem approved by the FDA?

KOSMO Femoral Stem received FDA 510(k) clearance on 2021-04-01, under approval number K202768.

What company makes KOSMO Femoral Stem?

KOSMO Femoral Stem is manufactured by B-One Ortho, Corp..

What is the FDA product code for KOSMO Femoral Stem?

The FDA product code for KOSMO Femoral Stem is LZO.

Other Devices by B-One Ortho, Corp.

K180446b-ONE Total Knee System K173380b-ONE® Total Hip System K182705Juveno Hip System Femoral Stem, b-ONE Primary Acetabular System Cups K183025MOBIO Total Knee System Posterior Stabilized (PS and PS+) Tibial Inserts, MOBIO Total Knee System Patellar Component K202429Mobio Total Knee System K212912OneFix Biocomposite Anchors, OneFix Biocomposite Small Anchors, OneFix All Suture Anchors, OneFix Interference Screws, OneFix Cannula System

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Related Devices (Code: LZO)

K160895Initia Total Hip System & BIOCERAM AZUL(R) HEADKyocera Medical Corporation K161830Zimmer M/L Taper Hip ProsthesisZimmer, Inc. K161192Wagner SL Revision Stem Lateral, Wagner Cone Prosthesis® SystemZimmer GmbH K152893Corin Optimized Positioning System (OPS)Corin USA K160289MasterLoc StemMedacta International K152903REVIVAL(TM) Modular Revision Hip StemCorin USA

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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